Browsing by Author "Pisco, J"
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- Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic HyperplasiaPublication . Martins Pisco, J; Bilhim, T; Vasco Costa, N; Torres, D; Pisco, J; Campos Pinheiro, L; Gouveia Oliveira, ABackground: Prostatic artery embolisation (PAE) has been associated with an improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH), but conclusive evidence of efficacy from randomised controlled clinical trials has been lacking. Objective: To assess the safety and efficacy of PAE compared with a sham procedure in the treatment of LUTS/BPH. Design, setting, and participants: A randomised, single-blind, sham-controlled superiority clinical trial was conducted in 80 males ≥45yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation. One patient in the PAE group and three in the sham group did not complete the study. Intervention: Patients were randomised 1:1 upon successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation. After 6 mo, all 38 patients randomised to the sham group who completed the single-blind period underwent PAE, and both groups completed a 6-mo open period. Outcome measurements and statistical analysis: An intention-to-treat analysis of all randomised patients was performed. The coprimary outcomes were the change from baseline to 6 mo in the International Prostate Symptom Score (IPSS) and the quality of life (QoL) score at 6 mo, analysed with analysis of covariance and t test, respectively. Results and limitations: Mean age was 63.8±6.0yr, baseline IPSS 26.4±3.87, and QoL score 4.43±0.52. At 6 mo, patients in the PAE arm had a greater improvement in IPSS, with a difference in the change from baseline of 13.2 (95% confidence interval [CI] 10.2-16.2, p<0.0001), and a better QoL score at 6 mo (difference: 2.13; 95% CI 1.57-2.68, p<0.0001) than the patients in the sham arm. The improvements in IPSS and QoL in the sham group 6 mo after they performed PAE were, respectively, 13.6±9.19 (p<0.0001) and 2.05 ± 1.71 (p<0.0001). Adverse events occurred in 14 (35.0%) patients after PAE and in 13 (32.5%) after sham, with one serious adverse event in the sham group during the open period. No treatment failures occurred. Limitations include a single-centre trial, only severe LUTS/BPH, and follow-up limited to 12 mo. Conclusions: The improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect. Patient summary: Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.
- Randomized Clinical Trial of Balloon Occlusion versus Conventional Microcatheter Prostatic Artery Embolization for Benign Prostatic HyperplasiaPublication . Bilhim, T; Costa, NV; Torres, D; Pisco, J; Carmo, S; Oliveira, APurpose: To compare balloon occlusion prostatic artery embolization (bPAE) with conventional microcatheter PAE (cPAE). Materials and methods: In this single-center trial, between November 2017 and November 2018, 89 patients with symptomatic benign prostatic hyperplasia were randomly assigned to cPAE (n = 43) or bPAE (n = 46). All patients received embolization with 300-500 μm Embosphere microspheres and were evaluated before and 1 and 6 months after PAE. Primary outcome measure was change from baseline in International Prostate Symptom Score (IPSS). Student t test was used for between-group comparisons of change from baseline, and paired t test was used for within-group comparisons. Results: At baseline, groups were identical (P > .05). Unilateral PAE was performed in 4 patients receiving cPAE and 3 patients receiving bPAE (9.30% and 6.52%, P = .708). Procedural and fluoroscopy times, dose area product, air kerma, embolic volume, and mean prostate-specific antigen (PSA) 24 hours after PAE did not differ between groups (P > .05). Coils were used in 6 patients receiving cPAE and 4 patients receiving bPAE (14.0% and 8.70%, P = .51). Assessments at 6 months after PAE showed mean IPSS reduction was 7.58 ± 6.88 after cPAE and 8.30 ± 8.12 after bPAE (P = .65); mean prostate volume reduction was 21.9 cm3 ± 51.6 (18.2%) after cPAE and 6.15 cm3 ± 14.6 (7.3%) after bPAE (P = .05); mean PSA reduction was 0.9 ng/mL ± 2.22 after cPAE and 0.22 ng/mL ± 1.65 after bPAE (P = .10). Penile skin lesions (n = 3) and rectal bleeding (n = 2) were documented only in patients receiving cPAE (11.9%, P = .01). No major adverse events occurred. Conclusions: bPAE is as effective as cPAE in treating benign prostatic hyperplasia with a potential to reduce nontarget embolization.
- The Role of Accessory Obturator Arteries in Prostatic Arterial EmbolizationPublication . Bilhim, T; Pisco, J; Campos Pinheiro, L; Rio Tinto, H; Fernandes, L; Pereira, JIn 9 of 491 patients (1.8%) who underwent prostatic arterial embolization (PAE) for benign prostatic hyperplasia from March 2009-November 2013, prostatic arteries arose from the external iliac artery via an accessory obturator artery (AOA). Computed tomography angiography performed before the procedure identified the variant and allowed planning before the procedure. The nine AOAs were catheterized from a contralateral femoral approach. Bilateral PAE was technically successful in the nine patients. There was a mean decrease in international prostate symptom score of 6.5 points and a mean prostate volume reduction of 15.1% (mean follow-up, 4.8 mo) in the nine patients.
- Tomografia Computorizada Cardíaca Prévia a Ablação de Fibrilhação Auricular - Efeitos da Evolução Tecnológica e Otimização de ProtocolosPublication . Marques, H; Araújo Gonçalves, P; Ferreira, AM; Cruz, R; Lopes, J; Santos, R; Radu, L; Costa, F; Mesquita, J; Carmo, P; Cavaco, D; Parreira, L; Pisco, J; Goyri O'Neill, J; Adragão, PIntrodução: A capacidade de a TC cardíaca fornecer um mapa anatómico preciso e excluir a presença de trombo intracardíaco é conhecida. O objetivo deste estudo foi avaliar o impacto da otimização de protocolos e evolução tecnológica nas doses de radiação e contraste e na qualidade de imagem dos exames de TC cardíaca prévia a ablação de fibrilhação auricular (FA). Métodos: Registo prospetivo de doentes consecutivos de centro único, foram incluídos os que fizeram TC cardíaca num contexto de avaliação prévia a ablação de FA (n = 270), distribuídos em três grupos: Grupo 1, constituído pelos primeiros 150 doentes; Grupo 2, os últimos 60 doentes feitos no mesmo aparelho; Grupo 3, os primeiros 60 doentes do novo aparelho. Avaliámos a otimização do protocolo com base na dose de radiação, no volume de contraste, na necessidade de aquisição complementar e na avaliação objectiva da qualidade de imagem (rácios sinal/ruído, contraste/ruído e homogeneizac¸ão de densidade AE/AAE). Resultados: Houve uma redução significativa da radiação entre cada um dos grupos e da dose de contraste entre o primeiro e o último grupo (G1: 5,6 mSv e 100 ml; G2: 1,3 mSv e 90 ml; G3: 0,6 mSv e 65 ml). Apesar das menores doses de radiação e contraste, o Grupo 3 apresentou resultados significativamente melhores de qualidade de imagem (rácios sinal/ruído 13,5; contraste/ruído 14,8; homogeneização de densidade 0,92).Conclusão: A otimização de protocolos e a evolução tecnológica permitiram reduções significativas nas doses de radiação e de contraste usadas na TC cardíaca pré-ablação de FA, sem prejudicar a qualidade de imagem.